Method and apparatus for a multi-use body fluid sampling device with optical analyte sensing

Abstract

A device for use with a penetrating member driver to penetrate tissue is provided. The device includes a single cartridge coupled to a plurality of penetrating members and operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of optical analyte sensors are coupled to the single cartridge and positioned to receive body fluid from a wound in the tissue created by the penetrating member.

1. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
 a single disposable; 
 an electronic drive force generator; 
 a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth; 
 a plurality of penetrating members coupled to said single disposable and operatively couplable to the electronic drive force generator, said penetrating members movable to extend radially outward from the disposable to penetrate tissue, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract; 
 a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and 
 a plurality of optical analyte sensors, each of an optical analyte sensor being positioned in a sample chamber to receive body fluid from the wound in the tissue created by the penetrating member, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and 
 an optical illumination system to provide illumination of at least a portion of the sample chamber. 
 
     
     
       2. The device of  claim 1  wherein the disposable includes a plurality of transparent windows aligned with said optical analyte sensors. 
     
     
       3. The device of  claim 1  wherein said penetrating members are slidably coupled to said disposable. 
     
     
       4. The device of  claim 1  wherein at least one optical analyte sensor is associated with at least one of said penetrating members. 
     
     
       5. The device of  claim 1  wherein said disposable is a flat radial disc. 
     
     
       6. The device of  claim 1  wherein said disposable has a diameter of less than 6 cm. 
     
     
       7. The device of  claim 1  wherein said disposable is a unitary body. 
     
     
       8. The device of  claim 1  wherein said penetrating members are not attached by a resilient member to the disposable. 
     
     
       9. The device of  claim 1  wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter. 
     
     
       10. The device of  claim 1  wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters. 
     
     
       11. The device of  claim 1  wherein said optical analyte sensors are mounted on said cartridge disposable. 
     
     
       12. The device of  claim 1  wherein each of said optical analyte sensors comprises an array of sensors. 
     
     
       13. The device of  claim 1  wherein each of said optical analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity. 
     
     
       14. The device of  claim 1  wherein each of said penetrating members are elongate members without molded attachments. 
     
     
       15. The device of  claim 1  wherein each of said penetrating members is made of only one material selected from the following: a metal or a metal alloy. 
     
     
       16. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
 a single disposable having a plurality of cavities; 
 an electronic drive force generator; 
 a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth; 
 a plurality of penetrating members coupled to said single disposable and couplable to the electronic drive force generator, said penetrating members movable to extend outward to penetrate tissue, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract; 
 a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and 
 a plurality of optical analyte sensors each of an analyte sensor positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and 
 an optical illumination system to provide illumination of at least a portion of the sample chamber. 
 
     
     
       17. The device of  claim 16  wherein the disposable includes a plurality of transparent windows aligned with said optical analyte sensors. 
     
     
       18. The device of  claim 16 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter. 
     
     
       19. The device of  claim 16 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 n a no liters. 
     
     
       20. The device of  claim 16 , wherein at least some of said optical analyte sensors are positioned on a bottom surface of said cavities. 
     
     
       21. The device of  claim 16 , wherein at least some of said optical analyte sensors are positioned on a side surface of said cavities. 
     
     
       22. The device of  claim 16 , wherein at least some of said optical analyte sensors are positioned on a top surface of said cavities. 
     
     
       23. The device of  claim 16 , wherein at least some of said optical analyte sensors are positioned on a curved surface of said cavities. 
     
     
       24. A device for use with a penetrating member driver to penetrate tissue, the device comprising:
 a single disposable having a plurality of openings and a plurality of penetrating member cavities; 
 an electronic drive force generator; 
 a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth; 
 a plurality of penetrating members at least partially contained in said cavities, each of a penetrating member being couplable to the electronic drive force generator, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract; 
 a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and 
 a plurality of optical sensors attached to a substrate, said substrate couplable to said single disposable in manner positioning at least one of said optical sensors with each of said plurality of cavities, each of a sensor being positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and 
 an optical illumination system to provide illumination of at least a portion of the sample chamber. 
 
     
     
       25. The device of  claim 24 , wherein disposable includes a plurality of optically transparent portions aligned with said optical analyte sensors. 
     
     
       26. The device of  claim 24 , wherein said substrate comprises a material selected from: polymer, metallic foil, or paper. 
     
     
       27. The device of  claim 24 , wherein said substrate comprises a laminate made from combinations of any of the following: polymer, metallic foil, or paper. 
     
     
       28. The device of  claim 24 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter. 
     
     
       29. The device of  claim 24 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters. 
     
     
       30. A body fluid sampling system comprising:
 a disposable; 
 an electronic drive force generator; 
 a processor coupled to the electronic drive force generator, the processor having programmable control over a velocity vs. position profile of a lancing process including at least one of, timing the start of the penetrating member, tracking penetrating member position, measuring penetrating velocity, controlling a distal stop acceleration, and controlling a skin penetration depth; 
 a plurality of penetrating members coupled to said disposable and selectively actuatable to penetrate tissue, said penetrating members extending radially outward to penetrate tissue, each of a penetrating member being couplable to the electronic drive force generator, the electronic drive force generator and a penetrating member creating a wound tract that remains open for a sufficient time to permit a flow of a body fluid from a wound tract; 
 a plurality of sample chambers in the single disposable, each of a sample chamber being associated with a penetrating member and including an aperture at an exterior surface of the single disposable configured to receive the body fluid from the wound tract; and 
 a plurality of optical analyte sensors coupled to said disposable, each of an optical analyte sensor being positioned in a sample chamber, wherein each of a sample chamber has a clear portion to allow light to pass for optical sensing; and 
 an optical illumination system to provide illumination of at least a portion of the sample chamber. 
 
     
     
       31. The system of  claim 30 , wherein disposable includes a plurality of optically transparent portions aligned with said optical analyte sensors. 
     
     
       32. The system of  claim 30 , further comprising a light source for providing excitation energy to one of said analyte sensors. 
     
     
       33. The system of  claim 30 , further comprising a dichroic mirror. 
     
     
       34. The system of  claim 30 , further comprising an optical sensor receiving reflected energy from one of said optical analyte sensors. 
     
     
       35. A system as in  claim 30 , wherein said drive force generator is configured to sequentially drive said penetrating members, each of said members moved from said launch position along a path into and out of the tissue site. 
     
     
       36. The system of  claim 30 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 1 microliter. 
     
     
       37. The system of  claim 30 , wherein said optical analyte sensors are configured to determine analyte levels using a body fluid sample of less than about 300 nanoliters. 
     
     
       38. The system of  claim 30 , wherein said optical analyte sensors are mounted on said disposable. 
     
     
       39. The system of  claim 30 , wherein each of said optical analyte sensors comprises an array of sensors. 
     
     
       40. The system of  claim 30 , wherein each of said optical analyte sensors comprises an array of sensors wherein a plurality of said array sensors have different ranges of analyte sensitivity. 
     
     
       41. The system of  claim 30 , wherein each of said penetrating members are elongate members without molded attachments. 
     
     
       42. The system of  claim 30 , wherein each of said penetrating members is made of only one material selected from the following: a metal or a metal alloy.